Guardian II and Guardian II NC hemostasis valves are used in catheterization procedures. Specific lots of the hemostasis valves have been recalled because they pose a slightly increased risk of air leakage that may lead to an air embolism, which could result in serious injury or death.
The recalled products were manufactured from February 2012 to February 2013 and distributed from February 2012 to February 2013. The recalled products are specific lots of Model Numbers 8210, 8211, 8215, 8216, 8241, 8242, 8244, 8272 and 8274. Healthcare facilities that have the affected Guardian II and Guardian II NC hemostasis valves should remove the products from their inventory and return them to Vascular Solutions.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall